Table 1.

Efficacy of oral sodium zirconium cyclosilicate in adults with hyperkalaemia in two phase III studies

Endpoint	SZC					Placebo
	1.25 g	2.5 g	5 g	10 g	15 g
ZS-003 [14]	(n = 154)	(n = 141)	(n = 157)	(n = 143)		(n = 158)
Mean exponential rate of change from BL in the serum potassium level per hour at 48 ha (%)	− 0.11	− 0.16**	− 0.21**	− 0.30**		− 0.09
Mean change from BL in serum potassium level at 48 h (mmol/L)	− 0.30	− 0.46**	− 0.54**	− 0.73**		− 0.25
Pts achieving serum potassium levels of 3.5–5 mmol/L at 48 h (%)	51.3	67.9**	77.6**	86.4**		47.8
Mean exponential rate of change from BL in serum potassium level/h over the maintenance perioda,b (%)	NR	NR	+ 0.09*	+ 0.14**		0.47/1.04c
ZS-004 (HARMONIZE) [15]			(n = 45)	(n = 50)	(n = 54)	(n = 82)
Mean serum potassium level during days 8–29 of maintenancea (mmol/L)			4.8**	4.5**	4.4**	5.1
Change from BL in serum potassium level at day 29 (mean mmol/L) [%]			− 0.8** [− 13.9**]	− 1.1** [− 19.3**]	− 1.2** [− 21.1**]	− 0.4 [− 7.7]
Pts achieving serum potassium levels of 3.5–5 mmol/L at day 29 (%)			71.1*	76.0*	85.2**	47.6
Pts achieving mean serum potassium levels of < 5.1 mmol/L during days 8–29 (%)			80.0**	90.0**	94.4**	46.3

Additional information obtained from the EU summary of product characteristics [8], the EU assessment report [12] and the US prescribing information [9]

BL baseline, NR not reported, pts patients, SZC sodium zirconium cyclosilicate

*p ≤ 0.01, **p ≤ 0.001 vs. placebo

^aPrimary endpoint

^bFor SZC 5 g and its respective placebo group in the maintenance period, n = 65 and 68; for SZC 10 g and its respective placebo group in the maintenance period, n = 63 and 61

^cValues for the SZC 5/10 g placebo groups, respectively